Human Research Protections- Standards & Regulations - page 6

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 Human Subjects Protections:
 2014 Edition of the International Compilation of Human Research Standards
This is a comprehensive collection of international human subjects protections regulations,
prepared by the U.S. Office for Human Research Protections (OHRP), and updated annually.
The regulations are organized by country and divided into seven categories:
1. General Research
2. Drugs and Devices
3. Research Injury
4. Privacy/Data Protection
5. Human Biological Materials
6. Genetic
7. Embryos, Stem Cells, and Cloning
 Department of Health and Human Services Policy for the Protection of Human Subjects (45
CFR part 46)
These are the U.S. Department of Health and Human Service’s codified regulations for the
protection of human subjects in research. They were developed based on the 1979 Belmont
Report and other work by the ‘National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research’. The ‘National Commission’ was formed in response to a
series of highly publicized abuses in research.
Excerpts from:
Subpart A of 45 CFR 46:
 IRB Functions and Operations and IRB Review of Research
 Criteria for IRB Approval of Research
 General Requirements for Informed Consent
 IRB Membership
 IRB Records
Subpart B of 45 CFR 46:
Additional Protections for Pregnant Women, Human Fetuses & Neonates Involved in Research